MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL TIGHTROPE WITH FIBERTAG
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unpackaged ar-1588rtt tightrope® batch 15466639 was received for investigation.Visual evaluation noted: white suture strands were torn.Blue suture strands were frayed and torn.Functional testing could not be performed due to the extent of the damage.The most likely cause for the reported failure can be attributed to user-related factors such as: contact with surgical instruments, excessive tension during the tightening process.The complaint allegation is confirmed.Refer to the investigation photos.
Event or Problem Description
It was reported that during the anterior cruciate ligament surgery of the right knee, the suture was torn out of the graft during femoral tightening.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24472602
• Report Number: 1220246-2026-01078
• Device Sequence Number: 9644363
• Product Code: MBI
• UDI-Device Identifier: 00888867308459
• UDI-Public: (01)00888867308459(11)250714(17)300630(10)15466639
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 15466639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Distributor Facility Aware Date: 01/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown